Model Number 866199 |
Device Problems
Erratic or Intermittent Display (1182); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/15/2023 |
Event Type
malfunction
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Event Description
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It was reported to philips that device has ecg intermittent malfunction when performing operational check and device is in clinical use but no reported adverse event.The efficia dfm100 defibrillator, model# 866199, is substantially similar to the heartstart xl+ defibrillator (model # 861290) and will be reported in the united states under device model # 861290.
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Manufacturer Narrative
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A follow up report will be submitted upon completion of the investigation.
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Event Description
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This report is based on information provided by philips remote service personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the efficia dfm100 defibrillator indicating that ecg equipment intermittent malfunction.There was no patient involvement.
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Search Alerts/Recalls
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